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Clinical Trials/NCT06672211
NCT06672211
Completed
Not Applicable

Effect of Video-Assisted Stoma Care Education Given to Patients With Stoma on Postoperative Anxiety, Adapting to Stoma and Complications: A Randomized Controlled Trial

Hatay Training and Research Hospital1 site in 1 country42 target enrollmentJanuary 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stoma - Ileostomy
Sponsor
Hatay Training and Research Hospital
Enrollment
42
Locations
1
Primary Endpoint
State-Trait Anxiety Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications.

Materials and Methods: This study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between January 2021 and September 2022 at the General Surgery Clinics of Aydın Atatürk State Hospital, Aydın State Hospital and Aydın Adnan Menderes University Practice and Research Hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. In the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. During the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.

Registry
clinicaltrials.gov
Start Date
January 10, 2021
End Date
September 10, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hatay Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Senem GÜNEŞ KARA

Wound Care Service Manager

Hatay Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Having a stoma
  • Being over 18 years old
  • Having no complications from the stoma

Exclusion Criteria

  • Having developed any complications in the stoma

Outcomes

Primary Outcomes

State-Trait Anxiety Scale

Time Frame: Pre-training 1 day and Post-training 1 day

The State Anxiety Inventory (STAI-I) was developed by Spielberger in 1970 and its Turkish form was adapted by Öner N. et al. for validity and reliability studies. While the anxiety level is scored as "(1) never, (2) a little, (3) a lot, and (4) completely" in the STAI-I, the options in the Trait Anxiety Inventory (STAI-II) are (1) almost never, (2) sometimes, (3) a lot, and (4) almost always. The scales include "straight" and reversed statements.

Secondary Outcomes

  • Adaptation Scale for Individuals with Stoma(1 day Pre-training and Post-training 1 day)
  • Pittman Ostomy Complication Severity Index(Post-training 1 week)

Study Sites (1)

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